Faisability and Efficacity of the Reinforced Communautary Support Program (PARC) on the Complications of Chemsex

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06610916
Status
Not Yet Recruiting

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Conditions

  • Addiction
  • Chemsex
  • Infections
  • Sexual Disorder, Physiological

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Reinforced Communautary Support Program (PARC) — OTHER
    Participants will complete the initial self-questionnaire collecting baseline socio-demographic, clinical characteristics, and all intermediate effectiveness outcome criteria \"before\". Concurrently with their participation in the program, they will complete various intermediate effectiveness evaluation questionnaires (\"after\") at 3 months (end of PARC) and 6 months (Post-PARC). Healthcare professionals running the PARC program will also complete questionnaires related to implementation indicators throughout the patients\' course (Adoption, Implementation, Maintenance). Qualitative interviews will be conducted with patients and relevant healthcare professionals to explore barriers and drivers to the optimal deployment of the PARC program and to examine each of the Reach, Adoption, Implementation, Maintenance indicators through an organizational approach

Study Details

The complications associated with chemsex concern infectious disease specialists, addiction specialists, and public authorities. Chemsex is defined among men who have sex with men (MSM) and trans and non-binary individuals participating in gay hookup networks due to their specific psychological, sexual, and social characteristics. The drugs used in France are cathinones (3MMC), GBL, and methamphetamine, administered orally, nasally, rectally, and intravenously (\"\"slam\"\"). Building on change models and health education theories, the teams at 190 and Spot Beaumarchais (AIDES) have created, within their shared facilities, the Parcours d\'Accompagnement Renforcé Communautaire (PARC), a multidisciplinary and community-based program providing comprehensive care for chemsex complications. The program aims to achieve clinical benefits: * Reducing addiction symptoms * Decreasing somatic, psychiatric, and social risks related to chemsex * Exploring and addressing the determinants of consumption and complications, especially psychological and psychiatric * Improving social connections * Maintaining life and professional goals * Perceiving or creating new types of connections between men * Resuming physical activity * Improving self-esteem * Finding a satisfying and fulfilling sexuality * Enhancing overall quality of life The goal of this study is to ensure that the PARC program, as designed, reaches its target population, is feasible, sustainable, at an acceptable cost, and improves the conditions of the population accessing it throughout the course. Thus, in the medium term, this study will identify all success factors for deploying such a program and build a toolkit for its dissemination to other regions with similar issues but somewhat different contexts. The primary objective is to evaluate the feasibility of the PARC program in terms of implementation by measuring patient adherence to the program. The primary outcome measure is the rate of patients who completed the follow-up in the PARC program compared to the number of patients who started the PARC program (at least the inclusion visit) over 18 months. A patient is considered adherent if they have attended at least one of each type of workshop offered during the first month AND continued to attend at least 4 workshops and 2 consultations per month during months 2 and 3. The secondary objectives are: 1. To evaluate the feasibility of the PARC program in terms of implementation, using the RE-AIM methodology (Glasgow): * Reach: Does the included patient population accurately represent the target population? Does patient loss represent the most vulnerable patients? * Intermediate Effectiveness at 3 months: (self-administered questionnaires) * Overall quality of life * Addiction criteria * Somatic complications * Social life * Sexual quality of life * Adoption of the intervention by professionals: Do addiction networks, CeGIDD, CSAPA, and city doctors refer their patients to the PARC program? * Implementation of the intervention: Has the program evolved from the beginning to the end of the study? Have there been adaptations? * Maintenance or sustainability: Is the financial model of the program sustainable and does it ensure a return on investment by analyzing the cost of care? 2. To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness. (qualitative analysis) The expected sample size is 60 patients included over a period of 18 months. Each patient will be included for a duration of 6 months, and the study will last for 24 months. Once included, participants will complete the initial self-questionnaire collecting baseline socio-demographic, clinical characteristics, and all intermediate effectiveness outcome criteria \"\"before\"\". Concurrently with their participation in the program, they will complete various intermediate effectiveness evaluation questionnaires (\"\"after\"\") at 3 months (end of PARC) and 6 months (Post-PARC). Healthcare professionals running the PARC program will also complete questionnaires related to implementation indicators throughout the patients\' course (Adoption, Implementation, Maintenance). Qualitative interviews will be conducted with patients and relevant healthcare professionals to explore barriers and drivers to the optimal deployment of the PARC program and to examine each of the Reach, Adoption, Implementation, Maintenance indicators through an organizational approach

Key Dates

First listed
Sep 24, 2024
Start date
Sep 20, 2024
Status verified
Sep 2024
Primary completion
Mar 20, 2026
Completion
Sep 20, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Reinforced Communautary Support Program (PARC)
    Participants will complete the initial self-questionnaire collecting baseline socio-demographic, clinical characteristics, and all intermediate effectiveness outcome criteria "before". Concurrently with their participation in the program, they will complete various intermediate effectiveness evaluation questionnaires ("after") at 3 months (end of PARC) and 6 months (Post-PARC). Healthcare professionals running the PARC program will also complete questionnaires related to implementation indicators throughout the patients' course (Adoption, Implementation, Maintenance). Qualitative interviews will be conducted with patients and relevant healthcare professionals to explore barriers and drivers to the optimal deployment of the PARC program and to examine each of the Reach, Adoption, Implementation, Maintenance indicators through an organizational approach

Primary Outcome Measure

Rate of patients who completed the follow-up in the PARC program as described in the model compared to the number of patients who started the PARC program (at least the inclusion visit) [ Time Frame: 18 months ]

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